FDA.report

Lifeport

Primary DI
H787LPS30065
Brand
Lifeport
Company
NAVILYST MEDICAL, INC.
Model
LPS 3006
Device description
LifePort Infusion Set
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K921674000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K921674000LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITEStrato Medical Corp.1992-09-23FPA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H787LPS30065PrimaryHIBCC0
15051684018494SecondaryGS10
H787LPS30060Unit of UseHIBCC0

GMDN Terms

TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Device Sizes

TypeValueUnit
Length1Inch
Needle Gauge19Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
809699023
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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